Phase III Clinical Study of Recombinant Human Erythropoietin(Eporon(R)) on Anemia of Chronic Renal Failure

Yu, Suk Hee; Kang, Chong Myung; Kang, Kyung Won; Lee, Ho Young; Noh, Hyun Jin; Shin, Suk Gyun

Abstract

To examine the effectiveness and safety of erythropoietin on the anemia of end-stage chronic renal failure, we administered recombinant human erythropoietin(rHuEPO), Eporon(R), to 66 patients with anemia and chronic renal failure who were undergoing hemodialysis or peritoneal dialysis. All received Eporon(R) intravenously, two or three times per week at 150unit/kg, and then the dose of Eporon(R) was adjusted to 75-300unit/kg/week according to the hemoglobin response. The results of this study judged 19(39.6%) of 48 patients as being in a "markedly improved" condition while 23(47.9%) of 48 patients were judged as being in an "improved" condition. At results, the response rate of this study was 87.5%(42/48 patients). This was the same as the target response rate, 90%(p= 0.564). Serious adverse events occured in 6 cases during the study, but all proved to be unrelated to Eporon(R). These events included itching 1(1.5%), urticaria 1(1.5%) and headache 1(1.5%). No patients discontinued to participate in the study except one patient who withdrew from the study voluntarily. The symptoms of all adverse events eventually decreased and disappeared during the clinical study. No factors in the clinical laboratory tests changed significantly (p<0.05) except for the decrease of TSR and ferritin, a consequence of using iron hemoglobin synthesis caused by Eporon(R) administration. The significant increase in blood pressure, which could not be proved to be related to Eporon(R), disappeared during the study. Anti-Epo antibody was not detected in any samples. These results demonstrate that Eporon(R) is effective in many patients with the anemia of end-stage chronic renal failure.